510(k) K971685

IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM by Tomey Corporation USA — Product Code HKI

K971685 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Tomey Corporation USA has at least 8 other 510(k) clearances on record.